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Nc305000

FDA UDI

Class II (US FDA UDI)

by Neochild, Llc

Identity

Trade Name
NC305000 FDA UDI
Generic Name
Single-administration urethral drainage/irrigation catheter FDA UDI
Device Name
5.0 Fr. Silicone Urinary Drainage Catheter FDA UDI
Model / Reference
NC305000 FDA UDI
Description
5.0 Fr. Silicone Urinary Drainage Catheter FDA UDI

Identifiers

Primary DI / UDI-DI
10816336020417 FDA UDI
510(k) Number
K060268 FDA UDI
FDA Product Code
GBM FDA UDI
GMDN Term
Single-administration urethral drainage/irrigation catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Single-administration urethral drainage/irrigation catheter

Nc305000 by Neochild, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-administration urethral drainage/irrigation catheter.

Cleared under the same submission

K060268 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neochild, Llc

Sources (1)

  • FDA UDI b38ce8d0-bf3e-450e-964d-772f0b77a9a4 35 fields · synced May 30, 2026